Overview
- The order halts manufacture, sale and distribution of immediate‑release nimesulide products above 100 mg with immediate effect, and companies must stop production and withdraw affected batches.
- The Health Ministry acted under Section 26A of the Drugs and Cosmetics Act after consultation with the Drugs Technical Advisory Board.
- Regulators cite evidence of severe liver injury at higher doses and note that safer alternatives are available for pain and fever.
- This is a targeted restriction rather than a blanket ban, with 100 mg strengths and other NSAIDs remaining available, and patients are advised to consult clinicians before changing medications.
- India had already banned nimesulide for children under 12 and, earlier this year, prohibited veterinary use after studies linked the drug to rapid vulture deaths.